Chronic Myelogenous Leukemia (ASC4MORE)

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Chronic Myelogenous Leukemia (ASC4MORE)

A Phase II, Multi-center, Open-label, Randomized Study of Oral Asciminib Added to Imatinib Versus Continued Imatinib Versus Switch to Nilotinib in Patients With CML-CP Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response.

Overview

This Study Is Recruiting: Phase II Actual Start Date: [November 22, 2018] Estimated Completion Date: [October 20, 2021] Novartis Reference Number: CABL001E2201
Condition: Chronic Myelogenous Leukemia in Chronic Phase Interventions: asciminib, nilotinib, imatinib Estimated Enrollment: [80 participants] ClinicalTrials.gov Identifier: NCT03578367
This Study Is Recruiting: Phase II Actual Start Date: [November 22, 2018]
Estimated Completion Date: [October 20, 2021] Novartis Reference Number: CABL001E2201
Condition: Chronic Myelogenous Leukemia in Chronic Phase Interventions: asciminib, nilotinib, imatinib
Estimated Enrollment: [80 participants] ClinicalTrials.gov Identifier: NCT03578367

Study Goal

To evaluate efficacy, safety and pharmacokinetic profile of asciminib 40mg+imatinib or asciminib 60mg+imatinib versus continued imatinib and versus nilotinib in pre-treated patients with Chronic Myeloid Leukemia in chronic phase (CML-CP).

All drugs are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Eligibility

Participants may be eligible to participate if they:

  • Are 18 years or older
  • Have confirmed diagnosis of CML-CP
  • Have minimum of 1 year treatment with imatinib first line for CML-CP
  • Have BCR-ABL1 ratio ≥ 0.01% IS and ≤ 1% IS at the time of study entry
  • Have not achieved deep molecular response (MR4) at any time during prior imatinib therapy
  • Meet other eligibility criteria

If you're interested in this clinical study, your doctor can help evaluate whether you are eligible to participate. Ask your doctor if your medical history or other treatments you're receiving may conflict with the study protocol. If you meet the eligibility criteria and agree to participate in the study: You will be required to sign an informed consent form (ICF). The ICF contains information about the study, which your doctor can help explain to you before you sign. Your doctor will need to complete the necessary tests to see if you are eligible. As with all clinical trials, you have the right to leave the study at any time, for any reason.

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Still Have a Question?

Are you a Patient, Caregiver or Health Care Professional looking for more information?

To view eligibility requirements for this trial, arms and interventions, trial sites and study design, please click to visit this trial on www.clinicaltrials.gov.

Other chronic myelogenous leukemia trials you might be interested in:

A Phase III, Multicenter, Open-label, Randomized Study of Oral Asciminib (ABL001) Versus Bosutinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP), Previously Treated With 2 or More Tyrosine Kinase Inhibitors.

Definitions:
BCR-ABL1 - Breakpoint cluster region-Abelson murine leukemia, CML-CP - Chronic myelogenous leukemia in chronic phase, ICF - Informed consent form, IS - International Scale

Last Updated: October 7, 2019

10/19 M-GON-1220477